Conference Compendium

3rd Annual Medical Device Validation Week

Medical Device Validation Week is the premier validation event for medical device and diagnostics professionals. The meeting on March 13-15, 2018 in Minneapolis, MN was one of the best ever, featuring distinguished FDA  speakers and providing expert insights and best practices on validation. 

Read the complete agenda.

This compendia will help your team: 

  • Examine key consideration in the global regulatory landscape
  • Tackle the complexities of supplier partnerships in validation 
  • Overcome challenges in TMV for diagnostics
  • Build a strategic plan for facility validation 
  • Delve into risk management in change control
  • Utilize risk to optimize V&V sampling plans
  • Learn more about risk management in change control 

Presenters included: 

  • CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer, Office of Compliance, Division of International Compliance Operations, Medical Device Single Audit Program, CDRH, U.S. FDA
  • Adam E. Saltman, M.D., Ph.D., FACS; Medical Officer, CDRH Office of Compliance, U.S. FDA
  • Francisco (Cisco) Vicenty, Program Manager, Case for Quality, Office of Compliance, CDRH, U.S. FDA
  • Roberta Goode, Principal, Altrec, LLC
  • Tim Carr, Staff Quality Engineer, Abbott - Tendyne
  • Ivonne del C. Ramos Miranda, Senior Validation Manager, Medtronic
  • Daniel Egeland, Ph.D., Senior Quality Assurance Professional, Design Quality Assurance, Abbott

**Bonus Materials Include**

Summary of significant regulatory changes

Gap assessment template

Checklist for CSV testing

Multiple MVP templates

Supplier on-site audit template

Read the complete agenda.

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